Cleared Traditional

ALVUE Balloon Dilation System (K171939) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K171939 · Globus Medical, Inc. · General & Plastic Surgery device
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Mar 2018
Decision
252d
Days
Class 2
Risk

K171939 is an FDA 510(k) clearance for the ALVUE Balloon Dilation System. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Globus Medical, Inc. (Audubon, US). The FDA issued a Cleared decision on March 7, 2018 after a review of 252 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Globus Medical, Inc. devices

Submission Details

510(k) Number K171939 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2017
Decision Date March 07, 2018
Days to Decision 252 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
137d slower than avg
Panel avg: 115d · This submission: 252d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GCJ Laparoscope, General & Plastic Surgery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GCJ Laparoscope, General & Plastic Surgery

All 477
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K171939.
AEON Retrieval Bag
K180114 · Lexington Medical, Inc. · Mar 2018
HX Device
K173919 · Human Extension , Ltd. · Mar 2018
Ezee Retrieval
K180579 · Genicon, Inc. · Mar 2018
Aesculap Video Assisted Thoracic Surgery (VATS) INstruments
K170683 · Aesculap, Inc. · Feb 2018
Ergonomic Handle
K173272 · Symmetry Surgical, Inc. · Feb 2018
Specimen Retrieval Bag
K172789 · Beijing Hangtian Kadi Technology R&D Institute · Feb 2018